Abstract

RATIONALE: Factors and outcomes associated with end-of-life decision-making among patients during clinical trials in the intensive care unit are unclear. OBJECTIVES: We sought to determine patterns and outcomes of Do Not Resuscitate (DNR) decisions among critically ill patients with acute respiratory distress syndrome (ARDS) enrolled in a clinical trial. METHODS: We performed a secondary analysis of data from the ARDS Network Fluid and Catheter Treatment Trial (FACTT), collected between 2000 and 2005. We calculated mortality outcomes stratified by code status, and compared baseline characteristics of patients who became DNR during the trial with participants who remained full code. MEASUREMENTS AND MAIN RESULTS: Among 809 FACTT participants with a code status recorded, 232 (28.7%) elected DNR status. Specifically, 37 (15.9%) chose to withhold cardiopulmonary resuscitation alone, 44 (19.0%) elected to withhold some life support measures in addition to cardiopulmonary resuscitation, and 151 (65.1%) had life support withdrawn. Admission severity of illness as measured by APACHE III score was strongly associated with election of DNR status (odds ratio, 2.2; 95% confidence interval, 1.85-2.62; P < 0.0001). Almost all (97.0%; 225 of 232) patients who selected DNR status died, and 79% (225 of 284) of patients who died during the trial were DNR. Among patients who chose DNR status but did not elect withdrawal of life support, 91% (74 of 81) died. CONCLUSIONS: The vast majority of deaths among clinical trial patients with ARDS were preceded by a DNR order. Unlike other studies of end-of-life decision-making in the intensive care unit, nearly all patients who became DNR died. The impact of variation of practice in end-of-life decision-making during clinical trials warrants further study.